JZP-6Treatment for Fibromyalgia
Update on FDA Advisory Committee Meeting For JZP-6
Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia
PALO ALTO, Calif., Aug. 20 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. announced today that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).
"While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA)," said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc. "We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way."
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see www.jazzpharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including statements related to future regulatory matters. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the uncertain and time-consuming regulatory approval process for JZP-6 and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August,11, 2010. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
Source: Jazz Pharmaceuticals, Inc.
CONTACT: Ami Knoefler, Executive Director, Investor Relations & Corporate Communications of Jazz Pharmaceuticals, Inc., +1-650-496-2947, firstname.lastname@example.org
Web Site: http://www.jazzpharmaceuticals.com/
Posted: August 2010
- Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia - October 11, 2010
- Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010 - June 25, 2010
- Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia - February 19, 2010
- Jazz Pharmaceuticals Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia - December 15, 2009